COREC recommend that information sheets are produced for the following age ranges, which broadly reflect cognitive stages of development.
- Children 5 years and under
- Children 6-12 years
- Children 13-15 years
and parents / guardians.
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Has the information sheet a clear and unambiguous heading? |
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Is the word 'Research' in the title of the consent form, and is it in bold? |
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Is the language throughout the sheet easy to understand? |
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What is the purpose of the study? |
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Why has this patient been chosen? |
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Does the patient have to take part? |
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What happens if the patient takes part? |
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Research methods - randomised trial, blind trial, cross-over trial, placebo |
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What does the patient have to do? |
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What drug or procedure is being tested? |
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What are the alternatives for diagnosis or treatment? |
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What are the side effects of taking part? |
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What are the possible disadvantages and risks of taking part? |
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What are the possible benefits of taking part? |
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Are the expenses/payment entitlements explained? |
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What will happend if the patient does not want to carry on? |
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What if new information becomes available (during the study)? |
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What happens after the research study? |
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What will happend to any samples given? |
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Will any genetic tests be done? |
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What if something goes wrong? |
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Will patient confidentiality be maintained? |
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What will happen to the results of the study? |
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Who is organising and funding the research? |
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Who has reviewed the study? |
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Who can the patient contact for further information? |